The present invention relates to a shipping or transport package.
Transport of hazardous goods, in particular medical samples, is subject to regulations from various regulatory bodies. The International Air Transport Association (IATA), a trade association of the world""s airlines, has promulgated regulations for transporting such hazardous goods by air. The IATA regulations prescribe requirements for security against leakage in general, and in particular against crush-induced leakage. There are different levels of regulation for different samples. The more hazardous is the sample, the more severe is the regulation. For example, IATA Transport of Dangerous Goods Regulation 650 prescribes requirements for shipping containers for relatively lower-risk materials that include diagnostic specimens and biological products, whereas Regulation 602 governs the shipping of relatively higher-risk materials such as samples known or reasonably expected to contain infectious microorganisms. Both of these regulations require that a package for shipping medical diagnostic or infectious samples have a water-tight primary container in which the sample is contained and a water-tight secondary container that contains the primary container. The package must have sufficient absorbent between the primary and secondary containers to absorb all liquid contained in the sample. Either the primary container or the secondary container must be able to withstand a pressure differential of 14 psi. Furthermore, the package must withstand a drop from a specified height onto a rigid floor. Packages containing infectious samples must also withstand a 7 kilogram rod dropped onto the package from a height of one meter.
A known medical sample transport package, to meet the severe regulations, includes:
a closed sample-tube containing the sample;
an envelope of absorbent material, into which the sample-tube is placed;
an inner plastics material bottle, which is sealable with the sample-tube and envelope enclosed;
an outer plastic bottle of heavier construction to provide crush strength; and
a cardboard box to receive the outer bottle for its dispatch through the mail, which routinely includes air freighting. Such a package is inevitably expensive.
U.S. Pat. No. 5,984,087 (Hacikyan) describes a packaging container comprising an envelope of water-insoluble material having a lining comprising a water-soluble material trapping an absorbent material. In the event of leakage, the water-soluble material dissolves releasing the absorbent material, which can soak up leaked liquid to prevent its release from the envelope. Similar products are disclosed in U.S. Pat. Nos. 4,748,069 and 4,853,266 (both to Cullen). A drawback of the products disclosed in these three patents is that the water-soluble material requires time to dissolve before the water-absorbent material is released, so giving liquid time to migrate and find escape routes. A further drawback is that these packages do not provide significant protection against crush-induced leakage.
International Patent Application WO95/16620 (Noax AB) discloses a package comprising a liquid impermeable layer and an absorbent layer, the absorbent layer possibly comprising super-absorber fibers or powder. Such a package does not provide significant protection against crush-induced leakage.
The parent application to the present application discloses a transport package that achieves substantial resistance to crush-induced leakage as well as meeting various other aspects of the applicable regulations for transporting hazardous samples by air. The package in preferred embodiments includes a substantially rigid tube formed of spirally wound paperboard plies for containing a primary container in the form of a sealed sample tube or vial. An innermost layer of the tube comprises a liner formed of absorbent material. The outermost layer of the tube can be a waterproof material. Removable end caps close the open ends of the spirally wound paperboard tube. With end caps suitably sealed to the tube, the transport package is capable of meeting all applicable regulations. It is a challenge, however, to provide the requisite degree of sealing of the end caps to the tube to meet the requirement of withstanding a 14 psi pressure differential, and to do so with a cost-efficient structure that is also convenient to use.
With the above-noted transport packages, the recipient of the package has no way of determining whether the sample vial contained in the package has leaked, except by opening the package, which may result in the recipient coming into contact with the leaked substance. This is clearly undesirable, particularly in the case of infectious samples. Thus, it would be desirable to be able to determine the condition of the sample while protecting the recipient against contact with any leaked material that may be present inside the package.
The present invention seeks to provide a shipping package that is convenient to use, and that achieves a substantial resistance to crushing and pressure differential in a relatively simple and cost-efficient manner. The invention in some embodiments also enables a person to visually check the condition inside the package before opening it. In accordance with a first aspect of the invention, a shipping package for protecting a fragile item such as a sample vial comprises a crush-resistant inner container comprising a tube formed from spirally wound fibrous plies adhered together, and an outer container surrounding the inner container. The outer container comprises a semi-rigid can formed of fluid-impervious, flexible polymer and has a receptacle portion and a closure portion releasably fastenable to the receptacle portion so as to render the outer container substantially impervious to fluid outside the outer container. Thus, crush-resistance is provided by the inner container, and resistance to fluid pressure is provided by the outer container. The outer container also can provide resistance to puncture when it is formed of a suitable polymer material and has a sufficient wall thickness.
The inner container can be formed of paperboard plies, and may additionally comprise other non-paperboard layers. Preferably, an innermost layer or liner of the tube is an absorbent material, which may incorporate a super-absorbent polymer.
The outer container preferably is formed of a polyethylene material, most preferably polyethylene teraphthalate. The outer container can be formed by various techniques, preferably by stretch blow molding. In a preferred embodiment of the invention, an open end of the receptacle portion of the outer container is threaded and the closure portion is threaded for releasably screwing onto the open end of the receptacle portion. The threaded engagement between the closure and receptacle portions enables a fluid-tight seal to be accomplished conveniently and cost-efficiently.
Preferably, at least a portion of the outer container is transparent to allow viewing into the interior of the outer container from outside thereof. In a particularly preferred embodiment, an open end of the inner container is adjacent an end wall of the outer container, and at least the end wall of the outer container is transparent to allow viewing into the open end of the inner container from outside the outer container. Accordingly, the condition inside the outer container can be assessed without having to open the outer container; in particular, visible evidence of leakage of a sample vial contained in the inner container may be seen from outside the outer container. The entire receptacle portion of the outer container preferably is transparent; thus, it is possible to view a label or other paperwork stored inside the outer container without having to open the outer container and remove the paperwork. The package preferably has an annular space between the inner and outer containers for storing the paperwork.
In one embodiment of the invention, the inner container is a tube open at both ends, and there are projections formed on the end wall of the receptacle portion and on the closure portion of the outer container that fit inside the open ends of the inner container to fix the inner container in position in the outer container. Alternatively, the projections can be formed on separate disks that are inserted into the receptacle portion of the outer container at opposite ends of the inner container. It is also possible to fix the inner container in the outer container by sizing the outer container to fit closely about the inner container.
A package in accordance with the invention can further comprise a shipping container surrounding the outer container. The shipping container can be a flexible bag or envelope, or a carton, for example.